Innovent's IBI343 Gets FDA Fast Track for Advanced Pancreatic Cancer

Innovent Biologics, Inc. (Innovent), a prominent biopharmaceutical company with a global footprint, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its anti-CLDN18.2 ADC known as IBI343. This drug is designed to treat advanced pancreatic ductal adenocarcinoma (PDAC), particularly in cases where the disease is unresectable or metastatic and has proved resistant to previous treatments. The FDA had previously approved the Investigational New Drug (IND) application for IBI343 targeting PDAC.

During the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO), Innovent shared encouraging preliminary results from Phase 1 trials of IBI343. In these trials, involving patients with advanced PDAC who had undergone at least one prior treatment, the drug showed a 40% overall response rate (ORR) in a specific dosage group. This promising outcome is particularly notable given the malignant nature of pancreatic cancer and the limited effectiveness of existing second-line treatments, which have response rates between 6% and 16% and median survival periods of just 3 to 6 months.

Dr. Hui Zhou, Senior Vice President of Innovent, emphasized the pressing need for better treatments for advanced pancreatic cancer. He noted that IBI343, the first CLDN18.2 ADC to receive FTD for this challenging cancer type, has demonstrated both effectiveness and a tolerable safety profile in late-line treatment settings. Innovent plans to continue investigating the drug’s efficacy and safety in ongoing clinical trials. The company is also exploring potential combination therapies and applications in other solid tumors, such as gastric cancer.

Fast Track Designation is an FDA process designed to expedite the development and review of drugs that address serious conditions and unmet medical needs. FTD status facilitates more frequent communication with the FDA, potentially speeding up the drug’s development and approval process.

Pancreatic cancer, particularly pancreatic ductal adenocarcinoma, is one of the most lethal forms of cancer, with a 5-year survival rate of just around 10%. Despite an increasing incidence, early diagnosis remains rare, severely impacting patient outcomes. Current treatments for advanced stages are largely limited to systemic chemotherapies like fluorouracil (5-FU) or gemcitabine in first-line settings, with very limited options for second-line treatments.

The drug IBI343 targets the protein Claudin 18.2 (CLDN18.2), a component of tight junctions in epithelial cells, which becomes exposed in tumor cells due to malignancy. This protein is found in a significant percentage of pancreatic cancer patients, making it an attractive target for new therapies. IBI343 is a monoclonal antibody-drug conjugate that binds to CLDN18.2-expressing tumor cells, leading to the internalization of the ADC and subsequent cell death through DNA damage and apoptosis. The drug also exhibits a "bystander killing effect," eliminating neighboring tumor cells.

In addition to its progress in the United States, Innovent has received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) of China for IBI343 in treating claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma. A Phase 3 trial is currently being prepared for this indication.

Founded in 2011, Innovent Biologics is committed to developing and commercializing innovative and affordable medicines for treating some of the most challenging diseases, including cancer and autoimmune disorders. The company boasts a robust pipeline with several products already in the market and many others in various stages of clinical development. Innovent collaborates with more than 30 global healthcare leaders and adheres to stringent industry practices to ensure the highest quality of biopharmaceuticals.